Guidelines for Pharmaceutical Stability Study : Pharmaguideline

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Guidelines for Pharmaceutical Stability Study

General consideration for the stability testing of the new pharmaceutical drug products including accelerated stability testing and long term stability testing conditions.
Following are the guidelines for stability study conduction for new products: 1. Formal stability study should consist of accelerated and long term stability testing on at least two primary production batches for stable drug products and in case of the susceptible drug products at least three primary production batches should be considered.
2. The accelerated stability testing data at 40°C / 75% for minimum six months and long term stability testing data at 30°C / 65% for minimum 12 months should be available at the time of submission for new drug application and can be continued further.
3. The product stable for 6 months at 40°C / 75% (Accelerated stability testing conditions) then it can be assigned the shelf life of 24 months.
4. If the shelf life period exceeding the 24 months is to be assigned to the product the real time stability testing data should be available.

5. Though not accepted internationally, as internal policy decision we can give the shelf life of 36 months if the product is found stable at accelerated stability testing conditions of 40°C / 75% for 12 months.
6. The shelf life of 36 months or more can be assigned to the drug formulation after completion of long term stability testing for 36 months or more.
7. If there is a change in the primary packing material the product should be treated as the new product for conduction of stability studies.
8. The stability studies should be performed on each individual strength of the drug product unless bracketing is applied.
9. If the same product is having the different doses (different strengths) and identical production formulation, and but different production process then each should be treated as a new product the stability study should be carried out separately for each of the strengths.
10. The frequency of the testing for long term stability testing should be initiated and after every 3 months over the first year, every 6 months over the second year and annually thereafter throughout the proposed shelf life.
11. The frequency of the testing for accelerated stability testing should be initial 3 months and 6 months.
12. While labeling the stability samples the terms ambient conditions or room temperature are not acceptable.

13. The stability testing should cover chemical, physical, biological and microbiological attributes including preservative content and the testing of those attributes of the drug products that are susceptible to change during storage and are likely to influence quality, safety and or efficacy of the drug product.
14. Out of three batches selected for stability study testing, the at least two batches should be pilot scale batches and the third one can be smaller if justified.
15. The photostability testing should be carried out on at least one primary batch of the drug product.

Also see: List of Current ICH Quality Guidelines for Stability

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

11 comments: Post Yours! Read Comment Policy ▼

  1. simply great work.......

  2. What is the testing frequency of samples in Accelerated stability studies as per WHO guidelines. (0,3,6 or 0,1,2,3,6) TRS-953 says a minimum of 3 points 0,3,6 is justified. Is there any guidelines which ask for 0,1,2,3,6 months

  3. is there any new guidelines for long term stability
    I got the new msg of 30/65 changes to 30/70 ?

    1. Which is your stability zone?

    2. No any change supposed change the condition then we have study to update ich guideline

  4. Anonymous10 December

    what is reference for all above if we are manufactured generic drugs

  5. Sir can u tell me about new guideline of stability

  6. Sir kindly guide if pharmaceutical item having storage temperature 2-8•c can be stored for one hour in 25 degree...

    1. Ideally no but check manufacturer guidelines for the same because it depends upon material.

  7. For a global company, if you have a stable product under Zone IV condition, is this accepted by all authorities for other zones like Zone I and II. Thus, are Zone IV stabity study also accepted for I and II and studies with lower temp and humity are not required for submission in Zone II? Thanks for anwer.

  8. What conditions are considered as an accelerated stability condition?


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